Device for screwing body tissue electrode into body tissue

ABSTRACT

A primary and auxiliary tool employed in implanting an electrical lead in body tissue, the primary tool having means associated therewith for holding the lead during implantation so as to avoid imparting torque to the lead, such means including a slotted end, a longitudinally extending groove and a longitudinally extending bore which communicates with the groove and the slotted end. The auxiliary tool which includes a body portion moveable in the bore, a ridge portion moveable in the groove, and a terminal portion moveable in the slotted end, serves to remove the lead from the primary tool after implantation of the electrode.

United States Patent Jula et al.

DEVICE FOR SCREWING BODY TISSUE ELECTRODE INTO BODY TISSUE Inventors:James L. Jula, 3880 Oak Tern,

White Bear Lake, Minn. 55110; Dennis Zeidler, 1835 134th Ln. N.E.,Anoka, Minn. 55303 Filed: Feb. 19, 1974 Appl. No.: 443,802

References Cited UNITED STATES PATENTS Bolduc 128/419 P Hon et a1.128/418 Apr. 8, 1975 Primary Examiner-Richard A. Gaudet AssistantExaminerLee S. Cohen Attorney, Agent, or F irm-Walter N. Kim, Jr.

[5 7 ABSTRACT A primary and auxiliary tool employed in implanting anelectrical lead in body tissue, the primary tool having means associatedtherewith for holding the lead during implantation so as to avoidimparting torque to the lead, such means including a slotted end, alongitudinally extending groove and a longitudinally extending borewhich communicates with the groove and the slotted end. The auxiliarytool which includes a body portion moveable in the bore, a ridge portionmoveable in the groove, and a terminal portion moveable in the slottedend, serves to remove the lead from the primary tool after implantationof the electrode.

8 Claims, 5 Drawing Figures DEVKCE FOR SCREWING BODY TISSUE ELECTRODEINTO BODY TISSUE BACKGROUND OF THE INVENTION This invention relates tothe field of medical electronics and particularly to an improved devicefor handling electrical leads having implantable body tissue electrodes.

U.S. Pat. No. 3,737,579 discloses a device or tool for holding anelectrical lead during body implantation in such a manner that byrotating the tool the helixshaped electrode can be screwed into placewithout imparting torque to the lead along its entire length. The leador electrode assembly includes three functionally distinct sections: lan implantable, conductive helixshaped electrode affixed to an insulatedboot, (2) a flexible, insulatingly covered conductor, and (3) a plug orconnector for connection to a power source. The device or tool forholding this lead disclosed in the above mentioned patent includes threeelements which serve to hold the lead during implantation-a slotted end,a longitudinally extending groove, and a bore extending the length ofthe tool, and parallel to the groove. The slotted end has straight,uniplanar sides dimensioned to accomodate the boot with enoughcompression to retain the boot in the slot during the implantationprocedure yet permitting removal of the boot from the slot withoutdisturbing the implanted helix. While the boot member has provedsatisfactory, some problems have been encountered in retaining the bootin the slot if the boot and/or the slot is wet, especially prior toinitially positioning the boot in the slot.

The longitudinally extending groove of the former device accomodates theflexible, insulatingly covered conductor during implantation while thebore receives the connector. Once the helix-shaped electrode isimplanted in the body tissue, the lead is disengaged from the tool inthree steps; first, removal of the connector from the bore; secondremoval of the boot member from the slotted end; and third, removal ofthe flexible conductor from the groove. The second step is preferablyaccomplished by an auxiliary tool shaped like a knitting needle which isinserted through the bore until the end of the needle-shaped tool pushesthe electrode boot out of the slot. This operation does not, however,simultaneously remove the flexible, insulatingly covered conductor fromthe groove. Depending upon the tightness of the grip between the outersurface of the flexible conductor and the groove, freeing of theflexible conductor can be a cumbersome task in the surgical environment.

In the present invention, there is provided a device for use in screwingthe conductive uninsulated distal end portion of a body implantableelectrode assembly into body tissue, said assembly being of the typeinclud ing a flexible insulated electrical conductor having a proximalend thereof adaptable for connection to a power supply, said devicecomprising: (1) first means for firmly holding a portion of saidelectrode assembly near said uninsulated distal end portion thereof, (2)second means adapted to contact an insulated portion of said insulatedconductor for releasably holding said conductor to facilitate thescrewing of said distal end portion into body tissue and for preventingthe transmission of torque to said proximal end of said conductor meanswhen said distal end portion is being screwed into body tissue, and (3)third means communicating with said first and second means whereby saidelectrode is releasable from said first and second means by meanslocatable in said third means. 7

A second or auxiliary device for use in combination with theabove-defined primary device is also provided, such auxiliary deviceincluding a first portion moveable in the third means of the primarydevice, a second portion associated with the first portion and moveablein the second means of the primary device, and a third portion moveableinto the first means of the primary device whereby movement of theauxiliary device into operative position with respect to the primarydevice removes the implantable electrode from the primary device. Aswill be seen hereinafter, this auxiliary device permits the boot-shapeddistal end of the lead to be removed from the slotted end of the primarydevice in the same operation as the flexible, insulatingly coveredconductor from the groove of the primary device.

Drawings are provided wherein:

FIG. 1 is a perspective view of the primary device of this inventionholding an implantable lead;

FIG. 2 is a perspective view of the auxiliary device of this invention;

FIG. 3 is a transverse sectional view of the primary and auxiliarydevices in an operative position;

FIG. 4 is an enlarged top view of the working end of the primary device;and

FIG. 5 is a sectional view taken along lines 5-5 of FIG. 4.

In FIG. 1 an implantable lead 1 is held by device 3. Lead 1, which isessentially the same as lead 10 depicted in FIG. 1 of U.S. Pat. No.3,737,579, includes a flexible conductor 7 of wrapped platinum wire orother suitable conducting material adaptable to the internal environmentof a human or animal body.

Affixed to the proximal end of conductor 7 is an electrical connector 9having a tip or extension 11 which may be connected to a suitableimplantable or external power supply. Affixed to and serving as thedistal end portion of conductor 7 is a rigid helical electrode 13 (seeFIG. 3) having several convolutions. Helical electrode 13 is a rigidcoil which may, for example, be made of platinum/irridium and terminatesin a sharply pointed end 15. Electrode 13 serves as the distal endportion of conductor 7 which may be screwed into body tissue as will beexplained later. Electrode l3 and conductor 7 are electrically joinedtogether by conductive epoxy (not shown) substantially orthogonally withrespect to one another and this electrical junction is contained in arubber boot l7.

Conductor 7, connector 9 and boot 17 are covered with a relativelytransparent, flexible, insulating covering being relatively inert withrespect to the body, which, for example, may be a silicone rubber casing19. The portion of casing 19 surrounding boot 17 forms a raised portionor projection 21. The distal portion of casing 19 is terminated andshaped as a circular disc 20 through which helical electrode 13projects. Helical electrode 13 projects through the disc 20 atsubstantially a right angle to conductor 7. Affixed to the under surfaceof the disc is a circular sheet of netting 23, which may, for example,be made of Dacron, a trademark of E. l. DuPont DeNemours and Company fora type of polyester fiber. Netting 23 enhances fibrotic growth, furtherinsuring a secure connection of the electrode to the tissue.

The device 3 is adapted to hold lead 1 at three places; the boot 17,casing 19, and connector 9. Device 3 comprises a substantiallycylindrically-shaped body 25 having a longitudinal axis 27 and endsurfaces 29 and 31. Device 3 may be made, for example, of a hard plasticmaterial such as Delrin, a trademark of the E. I. Du- Pont DeNemours andCompany for acetal resins. Preferably device 3 should be made of anautoclavable material. Formed in end surface 29 is a slot 33. Slot 33includes a frontal opening 35 leading to a cavity 37. The width ofcavity 37 is greater than the width of frontal opening 35. The widths offrontal opening 35 and cavity 37 are selected such that boot 17 must belaterally compressed to a slight degree in order to pass through frontalopening 35. Once at least a portion of boot 17 is past the shoulders 38,that portion resumes its original shape. To remove boot 17 from slot 33requires recompressing such portion in order to gain withdrawal fromfrontal opening 35. The shape of slot 33 and boot 17 is designed suchthat the force required to achieve the requisite compressive state isgreater than the forces that might be encountered in the implantationprocedure but insufficient to disturb the implanted electrode 13 as theboot 17 and slotted end 29 are being separated. Formed in the outersurface of device 3, lying in a plane substantially parallel to axis 27,and extending from end surface 31 for substantially the entire length ofdevice 3, is a groove 39. Groove 39, which is substantially aligned withslot 33, is adapted to receive and securely engage at least a portion ofthe length of casing 19. End surface 31 includes a slot 40 whichcommunicates with a central bore 41. Central bore 41 includes a firstsection 42 which extends slightly beyond groove 39 and a second section44 of reduced diameter which is concentric with section 42. Section 42of bore 41 is adapted to receive at least a portion of the proximal endoflead 1 including connector 9 and tip 11. Bore 41 communicates withgroove 39 the entire length of groove 39. At the approach to end 29,groove 39 provides a terminal portion 46 which slants downward towardsend 29 until it merges with bore 41. As will be seen hereinafter thisterminal portion of groove 39 is shaped to accomodate the terminalportion of an auxiliary tool. The cross-sectional dimension of groove 39is preferably less than the crosssectional dimension of section 42 ofbore 41. Groove 39 is wide enough to receive and hold casing 19, yetpreferably not so wide that casing 19 is able to drop into section 42 ofbore 41.

In FIG. 2 there is shown an auxiliary tool 43 for use in combinationwith the device 3. Tool 43 includes a substantially cylindrical bodyportion 45, a terminal portion 47, and a ridge portion 49. Body portion45 is designed to slide freely in bore 41 of device 3. As body portion45 advances in bore 41 from end 31 to end 29, ridge portion 49simultaneously advances in groove 39. Ridge portion 49 should be of sucha size and shape that it is freely slidable in groove 39 and will pushor wedge the casing 19 out of groove 39 as it slides along. Ridgeportion 49 is preferably relatively thin, with flat, parallel sidewalls. The leading edge 51 of ridge portion 49 preferably slantsdownwardly to meet body portion 45 at the terminal portion 47. Terminalportion 47 is tapered to a centered point 53. This allows the casing 19to be pushed forward and upward out of groove 39 rather than justforward. Terminal portion 47 is generally conically-shaped with the coneapex (end 53) being sufficiently blunt so that it will push rather thanpenetrate boot 17 in slot 33. The terminal portion 47 is preferably ofsuch a size and shape that the length thereof which will extend from theend of section 44 of bore 41 is approximately equal to or slightlylonger than the depth of cavity 37. Auxiliary tool 43 may be constructedof the same material as device 3.

At the opposing end of terminal portion 47, tool 43 contains an aperture55 including a circular opening 57 and a slot 59 communicating therewithleading to the outersurface of body portion 45. Aperture 55 is providedto accomodate tip 11 of lead 1. As will be explained hereinafter, afterimplanting the helical electrode 13 in tissue and removing lead 1 fromdevice 3, the dangling tip 11 can be inserted into aperture 55 and tool43 used as a tunneling device to tunnel through subcutaneous tissue tobring lead 1 to a proper position for connection at tip 11 to a suitablepower supply.

FIG. 3 depicts the primary device 3 of FIG. 1 gripping the lead 1 at theslotted end 33 and partially along groove 39. Tool 43 has been insertedin bore 41 and advanced partially therealong towards slot 33. Thatsegment of casing 19 previously located in the section of groove 39which has been traversed by ridge portion 49 has been displaced fromgroove 39 whereas the remainder of casing 19 as well as boot 17 awaitdisplacement as tool 43 advances.

In explanation of the manner of using the present invention, the firststep is to secure the lead 1 to the device 3 as shown in FIG. 1. Theraised portion of boot 17 is fitted into frontal opening 35 withcompression and then at least a portion of boot 17 pushed into cavity 37to provide a secure hold of boot 17.

A small loop is left in the portion of casing 19 immediately proximal toboot 17 and then casing 19 is worked into groove 39 so as to be securelyheld in the groove against movement. Then connector 9 and tip 11 arethen doubled back for insertion into bore 41 as far as they will go. Inthis position the electrode 13 is positioned substantially parallel tolongitudinal axis 27 of device 3 and the assembly is now ready for theelectrode to be screwed into body tissue.

Pointed end 15 is placed against the tissue or organ and device 3 isrotated as indicated by the curved arrow. The diameter of the wound isconfined to the diameter of the wire of which helical electrode 13 isformed. As device 3 is rotated, helical electrode 13 is firmly screwedinto the tissue or organ until netting 23 firmly contacts the outersurface of the organ. Netting 23 helps to provide a more secure andpermanent placement of electrode 13 in the tissues in that the nettingpromotes more rapid fibrosis in and around the netting, as well asaround the disc 20 and raised portion 21 of casing 19.

When electrode 13 is firmly screwed into the tissue and netting 23firmly seated against the outer surface of the tissue or organ, theconnector end of lead 1 is removed from bore 41. Then, the auxiliarytool 43 is utilized as described above to progressively remove theportion of casing 19 lying in groove 39, and then the boot 17 held inslot 33, thereby freeing lead 1 from device 3. With the use of theimplantation procedure described, since boot 17 and a substantialportion of casing 19 are firmly secured during the rotation of device 3,no torque is transmitted to lead 1 and consequently to conductor 7. Inaddition, before, during. and after the insertion procedure, device 3 inno way contacts the helical convolutions of electrode 13, permitting avery positive action in screwing electrode 13 into the tissue atsubstantially a 90 angle.

After implantation, tip 11 may be inserted in aperture 55 of tool 43 andtool 43 then passed, terminal portion 47 end first, through subcutaneoustissue until the site is reached where tip 11 is to be connected to apower supply under the skin. The tip 11 is then removed from aperture 55and the electrical connection made. While tool 43 may be employed forthis purpose it is also possible to employ a tool of the same design andshape as tool 43 except that ridge 49 is absent, making the bodysubstantially cylindrical in shape with the other elements of tool 43retained.

What is claimed is:

1. A device for use in screwing the conductive uninsulated distal endportion of a body implantable electrode assembly into body tissue, saidassembly being of the type including a flexible insulated electricalconductor having a proximal end thereof adaptable for connection to apower supply, said device comprising: (1 first means for firmly holdinga portion of said electrode assembly near said uninsulated distal endportion thereof, (2) second means adapted to contact an insulatedportion of said insulated conductor for releasably holding saidconductor to facilitate the screwing of said distal end portion intobody tissue and for preventing the transmission of torque to saidproximal end of said conductor means when said distal end portion isbeing screwed into body tissue, and (3) third means communicating withsaid first and second means for allowing said electrode and saidconductor to be released from said first and second means by meanslocatable in said third means.

2. The device of claim 1 wherein said third means is an aperture.

3. The device of claim 1 wherein said device is substantiallycylindrically shaped.

4. The device of claim 1 wherein said second means comprises a grooveformed in the outer surface of said device and said third meanscomprises an aperture.

5. The device of claim 4 wherein said groove extends substantiallyparallel to the longitudinal axis of said device, and said aperturecommunicates with said groove along substantially the entire length ofsaid groove.

6. The device of claim 1 wherein said third means is anaxially-extending aperture extending from one end of said device to theother end.

7. The device of claim 1 wherein said first means comprises a firstportion located at one end of said device defining an external opening,and a second portion located interior of and in communication with saidfirst portion, said second portion defining an internal opening, saidinternal opening being wider than said external opening.

8. The device of claim 7 wherein said third means communicates with saidsecond portion of said first means whereby said distal end portion canbe removed from said first means by means inserted into said secondportion via said third means.

1. A device for use in screwing the conductive uninsulated distal endportion of a body implantable electrode assembly into body tissue, saidassembly being of the type including a flexible insulated electricalconductor having a proximal end thereof adaptable for connection to apower supply, said device comprising: (1) first means for firmly holdinga portion of said electrode assembly near said uninsulated distal endportion thereof, (2) second means adapted to contact an insulatedportion of said insulated conductor for releasably holding saidconductor to facilitate the screwing of said distal end portion intobody tissue and for preventing the transmission of torque to saidproximal end of said conductor means when said distal end portion isbeing screwed into body tissue, and (3) third means communicating withsaid first and second means for allowing said electrode and saidconductor to be released from said first and second means by meanslocatable in said third means.
 2. The device of claim 1 wherein saidthird means is an aperture.
 3. The device of claim 1 wherein said deviceis substantially cylindrically shaped.
 4. The device of claim 1 whereinsaid second means comprises a groove formed in the outer surface of saiddevice and said third means comprises an aperture.
 5. The device ofclaim 4 wherein said groove extends substantially parallel to thelongitudinal axis of said device, and said aperture communicates withsaid groove along substantially the entire length of said groove.
 6. Thedevice of claim 1 wherein said third means is an axially-extendingaperture extending from one end of said device to the other end.
 7. Thedevice of claim 1 wherein said first means comprises a first portionlocated at one end of said device defining an external opening, and asecond portion located interior of and in communication with said firstportion, said second portion defining an internal opening, said internalopening being wider than said external opening.
 8. The device of claim 7wherein said third means communicates with said second portion of saidfirst means whereby said distal end portion can be removed from saidfirst means by means inserted into said second portion via said thirdmeans.